Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes

活动 II 计划：2 型糖尿病的行为抑郁治疗

• 批准号: 8531236
• 负责人: Mary K. de Groot
• 金额: $ 59.58万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8531236
• 关键词: Address; Adherence; Adopted; Adoption; Adult; Advertisements; Affect; Aftercare; Antidepressive Agents; Appalachian Region; Behavior Therapy; Behavioral; Blood Glucose; Blood Pressure; Caring; Clinical Trials Design; Cognitive; Cognitive Therapy; Communities; Community Healthcare; Complications of Diabetes Mellitus; Coronary heart disease; County; Development; Diabetes Mellitus; Dietary Intervention; Effectiveness; Eligibility Determination; Epidemic; Exercise; Face; Funding; Glycosylated hemoglobin A; Health; Healthcare; Healthcare Systems; Incidence; Indiana; Individual; Intention; Intervention; Low-Density Lipoproteins; Measures; Mental Depression; Mental Health; Modality; Modeling; Moods; Non-Insulin-Dependent Diabetes Mellitus; Ohio; Outcome; Participant; Patients; Pharmaceutical Preparations; Physicians; Pilot Projects; Population; Poverty; Prevalence; Principal Investigator; Psychiatric Hospitals; Quality of life; Randomized; Randomized Controlled Trials; Recruitment Activity; Relative (related person); Resources; Rest; Risk; Rural; Rural Community; Sample Size; Sampling; Site; Testing; Time; Transportation; Treatment Cost; Universities; West Virginia; Work; arm; base; blood lipid; cardiovascular risk factor; community setting; comparative; comparative effectiveness; comparative treatment; cost; cost effectiveness; depressive symptoms; design; diabetes education; fasting glucose; follow-up; functional disability; glycemic control; group intervention; improved; innovation; medical schools; meetings; mortality; nutrition education; primary outcome; programs; rural area; secondary outcome; treatment as usual; treatment program; underserved rural area

DESCRIPTION (provided by applicant): The prevalence of type 2 diabetes (T2DM) has reached epidemic proportions nationally and within underserved rural areas . Economically impoverished populations show increased risk for the development of T2DM and worsened outcomes. Rural residents are disproportionately affected by poverty and barriers to health care that contribute to these outcomes. Depression (MDD) affects 1 in 4 patients with diabetes. Depression is associated with worsened blood glucose levels and diabetes complications. Depression and T2DM also result in significant costs including: financial demands on health care systems, decreases to adherence and quality of life, increased functional disability and early mortality due to a variety of causes. Cognitive behavioral therapy (CBT) and exercise have the capacity to work synergistically as a win-win strategy to improve both T2DM and MDD outcomes while reducing barriers to care endemic to rural regions. Our group conducted a successful pilot study (R34DK071545) entitled, Program ACTIVE (Appalachians Coming Together to Increase Vital Exercise) to test the feasibility of recruitment, retention and change in outcomes using CBT and community-based exercise among rural Appalachian adults with T2DM. We observed improvements in diabetes, MDD, and LDL-C outcomes at post-treatment and 3-month follow-up (3MFU) compared to baseline. A randomized controlled trial (RCT) of Program ACTIVE is proposed to test whether the combination behavioral treatment results in greater improvements in MDD and T2DM outcomes compared to exercise alone, CBT alone and usual care. The study will utilize a 2X2 factorial repeated measures RCT design in which participants will be assessed at baseline, immediately following the intervention (POST), 6- and 12-month follow-up time points. Intervention materials developed in the previous pilot study will be used. Two intervention sites serving rural central Appalachian counties of Ohio and West Virginia will be coordinated by the PI at Indiana University. A total sample of N=216 adults with T2DM and MDD will be recruited. Participants who meet eligibility criteria will be randomized at each site into 1 of 4 groups: usual care, CBT (10 individual sessions), community-based exercise (12 weeks) or CBT+EXER (10 individual sessions and 12 weeks of concurrent exercise). Intention-to-treat analyses will be conducted to assess primary and secondary outcomes. The study makes a significant contribution to the field by testing the effectiveness of separate and combination treatment modalities for T2DM and MDD in comparison to UC and implementing two manualized treatment programs (CBT and exercise) tailored for individuals with T2DM within community settings. The study is innovative in its approach to the design and implementation of the treatment of T2DM and MDD by creating a model for coordinated care for T2DM and MDD treatment across mental health and community exercise facilities and creating a sustainable program that can be adopted by community mental health and exercise facilities in rural regions nationally beyond the period of federal funding.

描述（由申请人提供）：2型糖尿病（T2DM）的患病率已在全国范围内和服务不足的农村地区达到流行比例。经济上贫困的人口显示出增加T2DM和结果恶化的风险。农村居民受到贫困和卫生保健障碍的影响不成比例的，这会导致这些结果。抑郁症（MDD）影响四分之一的糖尿病患者。抑郁症与血糖水平恶化和糖尿病并发症有关。抑郁症和T2DM还带来了巨大的成本，包括：对医疗保健系统的财务需求，减少依从性和生活质量，增加功能残疾和由于多种原因而引起的早期死亡率。认知行为疗法（CBT）和运动具有协同工作的能力，以作为提高T2DM和MDD结果的双赢策略，同时降低了农村地区的特有障碍。我们的小组进行了一项成功的试点研究（R34DK071545），标题为“主动计划”（阿巴拉契亚人一起增加至关重要的运动），以测试使用CBT和基于社区的锻炼的招聘，保留和变化的可行性。与基线相比，我们观察到糖尿病，MDD和LDL-C结果的改善和3个月的随访（3MFU）的改善。提出了一项计划活动的随机对照试验（RCT），以测试与单独运动，单独的CBT和常规护理相比，组合行为治疗是否会导致MDD和T2DM结果的改善。这项研究将利用2x2阶乘重复测量RCT设计，其中将在基线（邮政），6个月和12个月的随访时间点后立即评估参与者。将使用先前的试点研究中开发的干预材料。为俄亥俄州和西弗吉尼亚州中部阿巴拉契亚中部县提供服务的两个干预地点将由印第安纳大学的PI协调。将招募n = 216名成年人的n = 216名成年人。符合资格标准的参与者将在每个站点中随机分为4组中的1个：通常的护理，CBT（10个单独的会议），基于社区的运动（12周）或CBT+Exer（10个单独的会议和12周的并发运动）。将进行意图对治疗分析以评估主要和次要结果。与UC相比，该研究通过测试T2DM和MDD的单独和组合治疗方式的有效性，并实施两个在社区环境中为具有T2DM的人量身定制的手动治疗计划（CBT和锻炼），从而为该领域做出了重大贡献。这项研究在设计和实施T2DM和MDD的方法方面具有创新性，通过为在心理健康和社区锻炼设施中为T2DM和MDD治疗建立一个模型，并创建可持续的计划，并创建一个可持续的计划，该计划可以由全国范围内的农村地区的社区心理健康和锻炼机构在全国范围内的联邦资金时期内采用。